Ahmedabad, Jan 19: The bulk drug manufacturing facility of the Ahmedabad-based pharma major, Cadila Pharmaceuticals, located at Ankleshwar, has been accorded US FDA approval for its Fluoxetine HCL manufacturing facility. This is the first US FDA approval for this facility in India.According to company press release, with the approval, Cadila Pharma will now supply Fluoxetine bulk to Mallinckrodt, USA who will convert this drug into formulations for the US market. Fluoxetine is an anti-depressant and Cadila Pharma has a capacity to produce 1,000 kg in a month at its Ankleshwar unit. The US FDA approval to Cadila Pharma has come without any 483 comments which shows the competency of the group in its facilities, documentations etc.
The Ankleshwar facility of Cadila Pharma group encompasses one of the highest capacities in India to produce Loratidine (anti-histaminic), Glibenclamide (anti-diabetic) and Chloro Hexidine base (dis-infectant). The ethambutol plant at Ankleshwar was earlier approved by USFDA. The company is putting up a multipurpose plant at this location at a cost of Rs 10 crore during the current fiscal. Seventy-five per cent of the bulk drugs produced in this plant is exported to developed countries like US, Canada and Europe and the rest 25 per cent is used for captive and domestic market consumption.
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